Diabetes

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

• Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
• Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
• SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
• The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
• Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

• Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
• The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
• Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
• Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

• Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
• Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
• SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
• The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
• Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

• Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
• The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
• Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
• Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Apps designed to increase physical activity may be useful in increasing daily step counts for users who believe the intervention beneficial, but not for those who do not. The app’s effectiveness is notably influenced by how users perceive its utility.

METHODOLOGY:

• Researchers conducted a randomized controlled trial from February 2021 to May 2022 to evaluate the effectiveness of SNapp, an adaptive app designed to promote walking through tailored coaching content.
• Overall, 176 adults (76% women; mean age, 56 years) were randomly assigned to use the app plus tailored coaching content (SNapp group; n = 87) or only the step counter app (control group; n = 89).
• SNapp’s coaching content provided personalized feedback on step counts and recommendations for increasing walking, while also considering individual preferences for behavior change techniques.
• The primary outcome was the daily step count recorded by the app, which was updated on an hourly basis in a database over an intervention period of 12 months.
• Perceptions of ease of use and usefulness were assessed to determine their effect on the effectiveness of the app.

TAKEAWAY:

• Intervention group participants used the app nearly 30% of days, while those using the app alone showed almost identical use.
• The SNapp intervention did not significantly affect the step counts on average over time (B, −202.30; 95% CI, −889.7 to 485.1).
• Perceived usefulness significantly moderated the intervention effect of SNapp (B, 344.38; 90% CI, 40.4-648.3), but perceived ease of use did not (B, 38.60; 90% CI, −276.5 to 353.7).
• Among participants with a high perceived usefulness, the SNapp group had a higher median step count than the control group (median difference, 1260 steps; 90% CI, −3243.7 to 1298.2); however, this difference was not statistically significant.

IN PRACTICE:

“This study shows that perceived usefulness is also an important factor influencing behavioral effects. Hence, it is essential for apps to be perceived as useful to effectively improve users’ activity levels,” the authors wrote.

SOURCE:

The study was led by Anne L. Vos, PhD, of the Amsterdam School of Communication Research at the University of Amsterdam, in the Netherlands. It was published online on September 16, 2024, in the American Journal of Preventive Medicine.

LIMITATIONS:

The study’s recruitment strategy primarily attracted highly educated individuals, limiting generalizability. The app’s accuracy in measuring steps could be improved, as it sometimes underestimated step counts. Researchers also were unable to check if participants read messages from coaches.

DISCLOSURES:

The study was supported by grants from the Dutch Heart Foundation and the Netherlands Organisation for Health Research and Development. No relevant conflicts of interest were disclosed by the authors.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.

At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.

Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.

One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”

Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
 

The ‘Alarming’ Finding of CAD in Asymptomatic Patients

Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L. 

All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.

Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.

Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.

Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm², a lipid arch > 180 degrees, and macrophages. 

“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.

He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk. 

Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
 

Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D

Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.

Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages. 

Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.

Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.

Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).

“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
 

BMI: Often Overlooked in T1D, but a Major CVD Risk Factor

Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.

Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women. 

However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.

The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.

After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively. 

MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33. 

“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded. 
 

Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk

Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.

Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported. 

“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.

Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
 

A version of this article first appeared on Medscape.com.

MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.

At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.

Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.

One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”

Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
 

The ‘Alarming’ Finding of CAD in Asymptomatic Patients

Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L. 

All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.

Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.

Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.

Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm², a lipid arch > 180 degrees, and macrophages. 

“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.

He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk. 

Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
 

Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D

Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.

Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages. 

Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.

Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.

Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).

“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
 

BMI: Often Overlooked in T1D, but a Major CVD Risk Factor

Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.

Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women. 

However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.

The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.

After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively. 

MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33. 

“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded. 
 

Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk

Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.

Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported. 

“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.

Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
 

A version of this article first appeared on Medscape.com.

MADRID — Emerging data points to the urgent need for cardiovascular risk reduction in all adults with type 1 diabetes (T1D), including those who are young and those diagnosed in adulthood.

At the European Association for the Study of Diabetes (EASD) 2024 Annual Meeting, two entire oral abstract sessions were devoted to research examining cardiovascular risk specifically in people with T1D. There is increasing evidence that as with type 2 diabetes (T2D), clinical visits need to focus on other cardiovascular risk factors and glucose.

Findings included the evidence of severe coronary artery disease (CAD) in asymptomatic adults with T1D, increased risks for mortality and cardiac events in people diagnosed with T1D in adulthood, and a greater cardiovascular risk for those with overweight/obesity and among those with more cumulative exposure to both hyperglycemia and dyslipidemia.

One speaker, Dr. Rebecka Johanna Bergdal, of the Folkhälsan Research Center and the University of Helsinki, Finland, issued a “call to action,” saying, “We call on healthcare professionals to continue supporting and encouraging individuals with T1D towards better management of diabetes, including both glucose and lipid management.”

Session Moderator Krzysztof Strojek, MD, PhD, head of the Department of Internal Medicine, Diabetology and Cardiometabolic Diseases at the Medical University of Silesia, Katowice, Poland, told this news organization that all the data point in the same direction for T1D management, to “look not only at A1c and blood glucose control but also lipids, hypertension, smoking status, all these risk factors recognized in type 2 ... are also important in T1D.”
 

The ‘Alarming’ Finding of CAD in Asymptomatic Patients

Michal Dubsky, MD, PhD, of the Diabetes Centre, Institute for Clinical and Experimental Medicine, Prague, Czech Republic, presented findings from 62 asymptomatic patients with T1D for > 10 years (mean, 36 years), with a mean A1c of 7.5% (58 mmol/mol), and no prior history of cardiovascular disease (CVD). They had slightly elevated CVD biomarkers, including a mean low-density lipoprotein (LDL) cholesterol level of 2.33 mmol/L, lipoprotein (a) level of 15 nmol/L, and N-terminal pro-B-type natriuretic peptide level of 125.3 ng/L. 

All underwent a noninvasive carotid ultrasound and coronary artery calcium (CAC) scoring. Of those, 12 patients had a CAC score > 400 and/or presence of two or more carotid plaques identified as high-risk.

Those 12 patients underwent coronary angiography and had a total of 29 vessels examined by optical coherence tomography (OCT), “an invasive intravascular method for assessing coronary atherosclerosis that is far more sensitive than standard coronary angiography, especially for the detection of high-risk vulnerable plaques without a hemodynamically significant stenosis,” Dr. Dubsky explained.

Coronary angiography showed obstructive CAD in 5 of the 12 patients. Their mean calcium score was 950 and mean number of carotid plaques was 2.8. Features associated with plaque vulnerability included microphage accumulation in 24 vessels, lipid-rich plaques in 23, spotty calcium in 19, and neovascularizations in 13.

Thin-cap fibroatheroma, a strong predictor of plaque rupture, was present in 7 of the 12 patients (58.3%), and four had features of very high-risk plaques, defined as thin-cap fibroatheroma with a minimal lumen area < 3.5 mm², a lipid arch > 180 degrees, and macrophages. 

“Our study showed that asymptomatic T1D patients with high CAC score and carotid plaques had very severe OCT findings. We observed a significant proportion of high-risk lesions potentially associated with plaque rupture and risk of CV death. Therefore, we believe these patients should be treated as very high-risk with target LDL below 1.4 mmol/L (55 mg/dL), even though they are completely asymptomatic,” Dr. Dubsky concluded.

He added that because OCT is invasive and costly, the CAC score can be used to guide the decision for statin use, with any score above 100 considered elevated risk. 

Study coauthor Martin Haluzik, MD, professor of internal medicine in the Charles University, Prague, Czech Republic, told this news organization, “I think it’s very alarming because some of these are basically very healthy-looking young people, so you don’t really expect them to have significant cardiovascular complications already or significant plaques. I think it shows that we should be more proactive in looking into the risk of cardiovascular complications and in looking into the early cardiovascular changes.”
 

Later Diagnosis Doesn’t Always Protect: Risk Seen in Adult-Onset T1D

Yuxia Wei, a PhD student at the Institute of Environmental Medicine, Karolinska Institutet, Stockholm, Sweden, presented an analysis of data from Sweden’s national health databases comparing cardiovascular outcomes between 10,184 people diagnosed with T1D at ages 18-29 years, 30-39 years, and ≥ 40 years; another 375,523 people diagnosed with T2D at those ages; and 509,172 population controls matched for age, sex, and county.

Those diagnosed after age 40 years had higher A1c levels and were less likely to be using insulin pumps than those diagnosed at younger adult ages. 

Compared with population controls, at a median of about 7 years of follow-up, people with T1D had significantly higher all-cause mortality at all diagnosis age groups, with a hazard ratio of 1.71. This rose to 2.78 for those diagnosed at age 30-39 years.

Compared with those with T2D, the mortality risks weren’t significantly different at any age, but the risks for non-cardiovascular death, including from cancer and infection, were significantly higher among those diagnosed after age 40 years (1.31 overall). Those diagnosed with T1D at any adult age had lower risks for major cardiovascular events than those diagnosed with T2D. Hazard ratios ranged from 0.27 for those diagnosed at age 18-29 years to 0.78 for those diagnosed after the age of 40 years.

Smoking and A1c above target were the greatest contributors to mortality. Those two factors, along with body mass index (BMI), were the strongest contributors to major adverse cardiovascular events (MACE).

“Adult-onset T1D carries excess risk of death and cardiovascular disease, without obvious attenuation over age at diagnosis…Smoking, A1c, and BMI are the key factors to be managed to improve prognosis in adult-onset T1D,” Ms. Wei concluded.
 

BMI: Often Overlooked in T1D, but a Major CVD Risk Factor

Two studies examined the link between overweight/obesity and cardiovascular risk in T1D. One, by Laurence Salle, MCU PH, of the Endocrinology, Diabetes and Metabolic Diseases Department at CHU Limoges, France, was a prospective, longitudinal cohort study of 2367 people with T1D at 68 centers in France who didn’t have a cardiovascular history at baseline.

Of those, 51% had normal BMI (18.5-24.9), 31% had overweight (25-29.9), and 18% had obesity (≥ 30). Cardiovascular risk factors, including LDL cholesterol, triglycerides, and hypertension increased with an increasing BMI. The 10-year CVD risk was significantly higher for those with overweight (9.61%) and obesity (9.93%) than for those with normal weight (7.24%), in both men and women. 

However, BMI was found to be an independent predictor of 10-year high cardiovascular risk in men but not women, while waist:height ratio independently predicted risk in both men and women, Dr. Salle reported.

The second BMI study, from Enrique Soto-Pedre, MBBS, of the Division of Population Health and Genomics at the University of Dundee, Scotland, presented data on a retrospective follow-up from 1995 to 2019 of 1973 people with T1D aged > 18 years at diagnosis (42% women; mean age, 34.2 years; 18.9% had obesity.

After 10 years of follow-up, those with overweight and obesity had significantly higher odds of developing arterial hypertension, even among those taking angiotensin-converting enzyme inhibitors/angiotensin receptor blockers, with statistically significant adjusted hazard ratios of 1.73 and 3.37 for the obese and overweight groups, respectively. 

MACE were significantly more common among those with obesity, with an adjusted hazard ratio of 2.95, as was acute myocardial infarction, 3.33. 

“These results emphasize the importance of incorporating weight management into the overall management of individuals with T1D. No one has doubts about weight management in T2D, but in type 1, it’s not so clear. One of the main [concerns] would be safety [in terms of hypoglycemia],” Dr. Soto-Pedre concluded. 
 

Call for Action: Cumulative Glucose and Lipid Exposures Increase Risk

Dr. Bergdal presented data on the effects of cumulative glycemia and lipids on the risk for CAD in 3495 adults with T1D who had been diagnosed prior to the age of 40 years. The history of CAD or stroke was exclusion criteria. There were a total of 534 CAD events within a median follow-up of 19.4 years.

Cumulative glycemia, LDL cholesterol, triglycerides, and non–high-density lipoprotein cholesterol exposures were all significantly associated with CAD risk (P < .001 for all). With an adjustment for confounders, the highest tertile of glycemia was associated with a twofold increased risk for CAD. Both hyperglycemia and dyslipidemia were independently associated with CAD risk, Dr. Bergdal reported. 

“It’s important to minimize the time spent above A1c 7%, and lipid management in T1D must not be forgotten,” she said, prior to issuing her call for action.

Dr. Haluzik reported receiving honoraria for talks and/or consultancy and/or research funding from Eli Lilly, Novo Nordisk, Sanofi, AstraZeneca, Mundipharma, Bristol Myers Squibb, Amgen, Boehringer Ingelheim, Janssen, Ypsomed, and Johnson & Johnson. The presenters had no disclosures.
 

A version of this article first appeared on Medscape.com.

Presented at the European Association for the Study of Diabetes (EASD) 2024 congress in Madrid, the QWINT-2 study established that once-weekly dosing of insulin efsitora was as effective as once-daily dosing of insulin degludec for reducing A1c in patients with type 2 diabetes (T2D) who had not previously received insulin. Study participants were, however, receiving noninsulin glucose-lowering agents, including glucagon-like peptide 1 (GLP-1) receptor agonists. 

Slightly higher rates of mild to moderate hypoglycemia were noted with efsitora compared with degludec, but no significant differences in severe hypoglycemia were observed. Nor was there any difference in weight gain between groups, and adverse events were balanced between study arms. 

This study positions insulin efsitora alongside once-weekly insulin icodec as a novel long-acting insulin therapy. In the ONWARDS 3 trial, icodec was noninferior to once-daily degludec, in terms of A1c reduction. It also had an adverse effect profile like that of efsitora with respect to hypoglycemia and weight change.

So, what are the implications of a once-weekly insulin for primary care?

“Game-changer” is an overused term, but from the perspective of primary care, it applies to once-weekly insulin.

I initiate basal insulin much less frequently these days, given the multitude of noninsulin options now available to me in primary care, particularly the GLP-1 receptor agonists and the dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonists. The American Diabetes Association/EASD 2022 consensus report also reminds me that GLP-1 receptor agonists should be considered in all individuals with T2D before insulin, unless they are contraindicated. GLP-1 receptor agonists are insulin-sparing agents with a lower injection burden and a lower risk for hypoglycemia. They also promote significant weight loss compared with basal insulin.

But progressive beta-cell decline and insulin deficiency are among the key pathophysiologic abnormalities in T2D. Eventually, many patients with T2D, despite lifestyle interventions and medication adherence, do require insulin. 

Understandably, many of my patients have reservations about commencing insulin. Significant stigma about starting insulin persists, because others often perceive insulin use as a failure to manage T2D. Patients frequently fear injections, and many are worried about how insulin therapy, specifically the risk for hypoglycemia, will affect their daily activities such as driving. 

Clinicians often experience therapeutic inertia, hesitating to escalate therapy to insulin because of a lack of confidence and competence, which often results from inadequate education. Lengthy referral-to-treatment waiting times are common in the United Kingdom, and there is concern about the workload implications associated with insulin initiation.

Workload is a particular concern for my community nursing colleagues, who must visit some of my more frail and functionally dependent patients daily to administer their insulin. 

In addition, the delivery of high-quality diabetes care in nursing homes, particularly for patients requiring insulin, has been a perennial challenge in the UK, again because of a lack of confidence and competence due to an absence of education for nursing and ancillary staff. 

Moreover, it is not appropriate to switch many of these frail patients to noninsulin therapies because of their insulinopenia, as well as the significant weight (and sometimes muscle) loss associated with GLP-1 receptor agonists. Also, sodium-glucose cotransporter 2 inhibitors are associated with a risk for volume depletion and diabetic ketoacidosis.

I believe that the availability of a once-weekly insulin will help overcome many of the above barriers.

From a patient’s viewpoint, simplification of insulin therapy with once-weekly insulin will substantially reduce the number of injections required (from 365 to 52 over 1 year). This change will improve compliance and concordance even in patients with injection anxiety. These results will hopefully translate into improved glycemic control and a lower risk for the complications of T2D. Real-world evidence for these outcomes is not yet available, however. Also, the reduced amount of insulin consumables that once-weekly dosing requires will also help improve the environmental footprint of insulin therapy.

From a clinician’s viewpoint, once-weekly insulin may seem less daunting and could reduce therapeutic inertia, thus facilitating earlier initiation of insulin therapy and reducing the risk for complications of T2D. Although education remains pivotal, this ease of dosing may be more acceptable to many clinicians because it has less of an effect on workload. This dosing could even save time because it requires less intensive follow-up than daily basal insulin does.

My community nurse colleagues were ecstatic when I mentioned that once-weekly basal insulin was on the horizon. This formulation could reduce the number of weekly home visits from 7 to just 1, thus freeing up considerable healthcare resources. And if once-weekly insulin is coupled with continuous glucose monitoring, then remote review of glucose data can further streamline and optimize the management of T2D in frail older patients. I am sure that my nursing-home colleagues will be equally enthusiastic about simplifying insulin regimens and monitoring.

Finally, an unanswered question is how I manage “sick days” for patients on weekly insulin dosing. Of course, the golden rule of never stopping insulin during intercurrent illness must be followed, but is any dose titration required for once-weekly insulin? I suspect not, but do I need to consider adding a once-daily basal insulin or rapid-acting insulin to mitigate the glucose counterregulatory hormone response during acute illness? Initially, I will be asking specialist diabetes teams for further advice on managing sick days.

In conclusion, once-weekly dosing of insulin is a game-changer for primary care and could finally be the driver to quash therapeutic inertia and address common patient barriers when escalation to insulin is required.

Dr. Fernando, general practitioner partner, North Berwick Health Centre, North Berwick, Scotland, disclosed ties with Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Daiichi Sankyo, Lilly, Menarini, Novartis, Novo Nordisk, Roche Diagnostics, Embecta, Roche Diabetes Care, and Sanofi.

A version of this article appeared on Medscape.com.

Presented at the European Association for the Study of Diabetes (EASD) 2024 congress in Madrid, the QWINT-2 study established that once-weekly dosing of insulin efsitora was as effective as once-daily dosing of insulin degludec for reducing A1c in patients with type 2 diabetes (T2D) who had not previously received insulin. Study participants were, however, receiving noninsulin glucose-lowering agents, including glucagon-like peptide 1 (GLP-1) receptor agonists. 

Slightly higher rates of mild to moderate hypoglycemia were noted with efsitora compared with degludec, but no significant differences in severe hypoglycemia were observed. Nor was there any difference in weight gain between groups, and adverse events were balanced between study arms. 

This study positions insulin efsitora alongside once-weekly insulin icodec as a novel long-acting insulin therapy. In the ONWARDS 3 trial, icodec was noninferior to once-daily degludec, in terms of A1c reduction. It also had an adverse effect profile like that of efsitora with respect to hypoglycemia and weight change.

So, what are the implications of a once-weekly insulin for primary care?

“Game-changer” is an overused term, but from the perspective of primary care, it applies to once-weekly insulin.

I initiate basal insulin much less frequently these days, given the multitude of noninsulin options now available to me in primary care, particularly the GLP-1 receptor agonists and the dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonists. The American Diabetes Association/EASD 2022 consensus report also reminds me that GLP-1 receptor agonists should be considered in all individuals with T2D before insulin, unless they are contraindicated. GLP-1 receptor agonists are insulin-sparing agents with a lower injection burden and a lower risk for hypoglycemia. They also promote significant weight loss compared with basal insulin.

But progressive beta-cell decline and insulin deficiency are among the key pathophysiologic abnormalities in T2D. Eventually, many patients with T2D, despite lifestyle interventions and medication adherence, do require insulin. 

Understandably, many of my patients have reservations about commencing insulin. Significant stigma about starting insulin persists, because others often perceive insulin use as a failure to manage T2D. Patients frequently fear injections, and many are worried about how insulin therapy, specifically the risk for hypoglycemia, will affect their daily activities such as driving. 

Clinicians often experience therapeutic inertia, hesitating to escalate therapy to insulin because of a lack of confidence and competence, which often results from inadequate education. Lengthy referral-to-treatment waiting times are common in the United Kingdom, and there is concern about the workload implications associated with insulin initiation.

Workload is a particular concern for my community nursing colleagues, who must visit some of my more frail and functionally dependent patients daily to administer their insulin. 

In addition, the delivery of high-quality diabetes care in nursing homes, particularly for patients requiring insulin, has been a perennial challenge in the UK, again because of a lack of confidence and competence due to an absence of education for nursing and ancillary staff. 

Moreover, it is not appropriate to switch many of these frail patients to noninsulin therapies because of their insulinopenia, as well as the significant weight (and sometimes muscle) loss associated with GLP-1 receptor agonists. Also, sodium-glucose cotransporter 2 inhibitors are associated with a risk for volume depletion and diabetic ketoacidosis.

I believe that the availability of a once-weekly insulin will help overcome many of the above barriers.

From a patient’s viewpoint, simplification of insulin therapy with once-weekly insulin will substantially reduce the number of injections required (from 365 to 52 over 1 year). This change will improve compliance and concordance even in patients with injection anxiety. These results will hopefully translate into improved glycemic control and a lower risk for the complications of T2D. Real-world evidence for these outcomes is not yet available, however. Also, the reduced amount of insulin consumables that once-weekly dosing requires will also help improve the environmental footprint of insulin therapy.

From a clinician’s viewpoint, once-weekly insulin may seem less daunting and could reduce therapeutic inertia, thus facilitating earlier initiation of insulin therapy and reducing the risk for complications of T2D. Although education remains pivotal, this ease of dosing may be more acceptable to many clinicians because it has less of an effect on workload. This dosing could even save time because it requires less intensive follow-up than daily basal insulin does.

My community nurse colleagues were ecstatic when I mentioned that once-weekly basal insulin was on the horizon. This formulation could reduce the number of weekly home visits from 7 to just 1, thus freeing up considerable healthcare resources. And if once-weekly insulin is coupled with continuous glucose monitoring, then remote review of glucose data can further streamline and optimize the management of T2D in frail older patients. I am sure that my nursing-home colleagues will be equally enthusiastic about simplifying insulin regimens and monitoring.

Finally, an unanswered question is how I manage “sick days” for patients on weekly insulin dosing. Of course, the golden rule of never stopping insulin during intercurrent illness must be followed, but is any dose titration required for once-weekly insulin? I suspect not, but do I need to consider adding a once-daily basal insulin or rapid-acting insulin to mitigate the glucose counterregulatory hormone response during acute illness? Initially, I will be asking specialist diabetes teams for further advice on managing sick days.

In conclusion, once-weekly dosing of insulin is a game-changer for primary care and could finally be the driver to quash therapeutic inertia and address common patient barriers when escalation to insulin is required.

Dr. Fernando, general practitioner partner, North Berwick Health Centre, North Berwick, Scotland, disclosed ties with Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Daiichi Sankyo, Lilly, Menarini, Novartis, Novo Nordisk, Roche Diagnostics, Embecta, Roche Diabetes Care, and Sanofi.

A version of this article appeared on Medscape.com.

Presented at the European Association for the Study of Diabetes (EASD) 2024 congress in Madrid, the QWINT-2 study established that once-weekly dosing of insulin efsitora was as effective as once-daily dosing of insulin degludec for reducing A1c in patients with type 2 diabetes (T2D) who had not previously received insulin. Study participants were, however, receiving noninsulin glucose-lowering agents, including glucagon-like peptide 1 (GLP-1) receptor agonists. 

Slightly higher rates of mild to moderate hypoglycemia were noted with efsitora compared with degludec, but no significant differences in severe hypoglycemia were observed. Nor was there any difference in weight gain between groups, and adverse events were balanced between study arms. 

This study positions insulin efsitora alongside once-weekly insulin icodec as a novel long-acting insulin therapy. In the ONWARDS 3 trial, icodec was noninferior to once-daily degludec, in terms of A1c reduction. It also had an adverse effect profile like that of efsitora with respect to hypoglycemia and weight change.

So, what are the implications of a once-weekly insulin for primary care?

“Game-changer” is an overused term, but from the perspective of primary care, it applies to once-weekly insulin.

I initiate basal insulin much less frequently these days, given the multitude of noninsulin options now available to me in primary care, particularly the GLP-1 receptor agonists and the dual GLP-1/glucose-dependent insulinotropic polypeptide receptor agonists. The American Diabetes Association/EASD 2022 consensus report also reminds me that GLP-1 receptor agonists should be considered in all individuals with T2D before insulin, unless they are contraindicated. GLP-1 receptor agonists are insulin-sparing agents with a lower injection burden and a lower risk for hypoglycemia. They also promote significant weight loss compared with basal insulin.

But progressive beta-cell decline and insulin deficiency are among the key pathophysiologic abnormalities in T2D. Eventually, many patients with T2D, despite lifestyle interventions and medication adherence, do require insulin. 

Understandably, many of my patients have reservations about commencing insulin. Significant stigma about starting insulin persists, because others often perceive insulin use as a failure to manage T2D. Patients frequently fear injections, and many are worried about how insulin therapy, specifically the risk for hypoglycemia, will affect their daily activities such as driving. 

Clinicians often experience therapeutic inertia, hesitating to escalate therapy to insulin because of a lack of confidence and competence, which often results from inadequate education. Lengthy referral-to-treatment waiting times are common in the United Kingdom, and there is concern about the workload implications associated with insulin initiation.

Workload is a particular concern for my community nursing colleagues, who must visit some of my more frail and functionally dependent patients daily to administer their insulin. 

In addition, the delivery of high-quality diabetes care in nursing homes, particularly for patients requiring insulin, has been a perennial challenge in the UK, again because of a lack of confidence and competence due to an absence of education for nursing and ancillary staff. 

Moreover, it is not appropriate to switch many of these frail patients to noninsulin therapies because of their insulinopenia, as well as the significant weight (and sometimes muscle) loss associated with GLP-1 receptor agonists. Also, sodium-glucose cotransporter 2 inhibitors are associated with a risk for volume depletion and diabetic ketoacidosis.

I believe that the availability of a once-weekly insulin will help overcome many of the above barriers.

From a patient’s viewpoint, simplification of insulin therapy with once-weekly insulin will substantially reduce the number of injections required (from 365 to 52 over 1 year). This change will improve compliance and concordance even in patients with injection anxiety. These results will hopefully translate into improved glycemic control and a lower risk for the complications of T2D. Real-world evidence for these outcomes is not yet available, however. Also, the reduced amount of insulin consumables that once-weekly dosing requires will also help improve the environmental footprint of insulin therapy.

From a clinician’s viewpoint, once-weekly insulin may seem less daunting and could reduce therapeutic inertia, thus facilitating earlier initiation of insulin therapy and reducing the risk for complications of T2D. Although education remains pivotal, this ease of dosing may be more acceptable to many clinicians because it has less of an effect on workload. This dosing could even save time because it requires less intensive follow-up than daily basal insulin does.

My community nurse colleagues were ecstatic when I mentioned that once-weekly basal insulin was on the horizon. This formulation could reduce the number of weekly home visits from 7 to just 1, thus freeing up considerable healthcare resources. And if once-weekly insulin is coupled with continuous glucose monitoring, then remote review of glucose data can further streamline and optimize the management of T2D in frail older patients. I am sure that my nursing-home colleagues will be equally enthusiastic about simplifying insulin regimens and monitoring.

Finally, an unanswered question is how I manage “sick days” for patients on weekly insulin dosing. Of course, the golden rule of never stopping insulin during intercurrent illness must be followed, but is any dose titration required for once-weekly insulin? I suspect not, but do I need to consider adding a once-daily basal insulin or rapid-acting insulin to mitigate the glucose counterregulatory hormone response during acute illness? Initially, I will be asking specialist diabetes teams for further advice on managing sick days.

In conclusion, once-weekly dosing of insulin is a game-changer for primary care and could finally be the driver to quash therapeutic inertia and address common patient barriers when escalation to insulin is required.

Dr. Fernando, general practitioner partner, North Berwick Health Centre, North Berwick, Scotland, disclosed ties with Amarin, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Dexcom, Daiichi Sankyo, Lilly, Menarini, Novartis, Novo Nordisk, Roche Diagnostics, Embecta, Roche Diabetes Care, and Sanofi.

A version of this article appeared on Medscape.com.

TOPLINE:

The prevalence of diabetes in the United States increased by 18.6% from 2012 to 2022, with notably higher rates among racial and ethnic minorities, men, older adults, and socioeconomically disadvantaged populations.

METHODOLOGY:

• Over 37 million people in the United States have diabetes, and its prevalence is only expected to increase in the coming years, making identifying high-risk demographic groups particularly crucial.
• To assess recent national trends and disparities in diabetes prevalence among US adults, researchers conducted an observational study using data from the Behavioral Risk Factor Surveillance System and included 5,312,827 observations from 2012 to 2022.
• Diabetes was defined on the basis of a previous self-reported diagnosis using standardized questionnaires.
• The sociodemographic factors of age, sex, race, education, physical activity, income, and body mass index were used to establish the risk indicators for diabetes diagnosis.
• Age-standardized diabetes prevalence and the association between risk factors and diabetes were assessed both overall and across various sociodemographic groups.

TAKEAWAY:

• The overall prevalence of diabetes increased by 18.6% (P < .001) from 2012 to 2022, with the highest prevalence observed among non-Hispanic Black individuals (15.8%) and people aged ≥ 65 years (23.86%).
• The likelihood of being diagnosed with diabetes was 1.15 times higher in men than in women, 5.16 times higher in adults aged 45-64 years than in those aged 18-24 years, and 3.64 times higher in those with obesity than in those with normal weight.
• The risk for being diagnosed with diabetes was 1.60 times higher among Hispanic individuals, 1.67 times higher among non-Hispanic Asian individuals, and 2.10 times higher among non-Hispanic Black individuals than among non-Hispanic White individuals.
• Individuals with a college education and higher income level were 24% and 41% less likely, respectively, to be diagnosed with diabetes.

IN PRACTICE:

“Improving access to quality care, implementing diabetes prevention programs focusing on high-risk groups, and addressing social determinants through multilevel interventions may help curb the diabetes epidemic in the United States,” the authors wrote.

SOURCE:

The study, led by Sulakshan Neupane, MS, Department of Agricultural and Applied Economics, University of Georgia, Athens, Georgia, was published online in Diabetes, Obesity, and Metabolism.

LIMITATIONS:

The self-reported diagnoses and lack of clinical data may have introduced bias. Diabetes prevalence could not be analyzed in South-East Asian and South Asian populations owing to limitations in the data collection process.

DISCLOSURES:

The study was not supported by any funding, and no potential author disclosures or conflicts were identified.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The prevalence of diabetes in the United States increased by 18.6% from 2012 to 2022, with notably higher rates among racial and ethnic minorities, men, older adults, and socioeconomically disadvantaged populations.

METHODOLOGY:

• Over 37 million people in the United States have diabetes, and its prevalence is only expected to increase in the coming years, making identifying high-risk demographic groups particularly crucial.
• To assess recent national trends and disparities in diabetes prevalence among US adults, researchers conducted an observational study using data from the Behavioral Risk Factor Surveillance System and included 5,312,827 observations from 2012 to 2022.
• Diabetes was defined on the basis of a previous self-reported diagnosis using standardized questionnaires.
• The sociodemographic factors of age, sex, race, education, physical activity, income, and body mass index were used to establish the risk indicators for diabetes diagnosis.
• Age-standardized diabetes prevalence and the association between risk factors and diabetes were assessed both overall and across various sociodemographic groups.

TAKEAWAY:

• The overall prevalence of diabetes increased by 18.6% (P < .001) from 2012 to 2022, with the highest prevalence observed among non-Hispanic Black individuals (15.8%) and people aged ≥ 65 years (23.86%).
• The likelihood of being diagnosed with diabetes was 1.15 times higher in men than in women, 5.16 times higher in adults aged 45-64 years than in those aged 18-24 years, and 3.64 times higher in those with obesity than in those with normal weight.
• The risk for being diagnosed with diabetes was 1.60 times higher among Hispanic individuals, 1.67 times higher among non-Hispanic Asian individuals, and 2.10 times higher among non-Hispanic Black individuals than among non-Hispanic White individuals.
• Individuals with a college education and higher income level were 24% and 41% less likely, respectively, to be diagnosed with diabetes.

IN PRACTICE:

“Improving access to quality care, implementing diabetes prevention programs focusing on high-risk groups, and addressing social determinants through multilevel interventions may help curb the diabetes epidemic in the United States,” the authors wrote.

SOURCE:

The study, led by Sulakshan Neupane, MS, Department of Agricultural and Applied Economics, University of Georgia, Athens, Georgia, was published online in Diabetes, Obesity, and Metabolism.

LIMITATIONS:

The self-reported diagnoses and lack of clinical data may have introduced bias. Diabetes prevalence could not be analyzed in South-East Asian and South Asian populations owing to limitations in the data collection process.

DISCLOSURES:

The study was not supported by any funding, and no potential author disclosures or conflicts were identified.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The prevalence of diabetes in the United States increased by 18.6% from 2012 to 2022, with notably higher rates among racial and ethnic minorities, men, older adults, and socioeconomically disadvantaged populations.

METHODOLOGY:

• Over 37 million people in the United States have diabetes, and its prevalence is only expected to increase in the coming years, making identifying high-risk demographic groups particularly crucial.
• To assess recent national trends and disparities in diabetes prevalence among US adults, researchers conducted an observational study using data from the Behavioral Risk Factor Surveillance System and included 5,312,827 observations from 2012 to 2022.
• Diabetes was defined on the basis of a previous self-reported diagnosis using standardized questionnaires.
• The sociodemographic factors of age, sex, race, education, physical activity, income, and body mass index were used to establish the risk indicators for diabetes diagnosis.
• Age-standardized diabetes prevalence and the association between risk factors and diabetes were assessed both overall and across various sociodemographic groups.

TAKEAWAY:

• The overall prevalence of diabetes increased by 18.6% (P < .001) from 2012 to 2022, with the highest prevalence observed among non-Hispanic Black individuals (15.8%) and people aged ≥ 65 years (23.86%).
• The likelihood of being diagnosed with diabetes was 1.15 times higher in men than in women, 5.16 times higher in adults aged 45-64 years than in those aged 18-24 years, and 3.64 times higher in those with obesity than in those with normal weight.
• The risk for being diagnosed with diabetes was 1.60 times higher among Hispanic individuals, 1.67 times higher among non-Hispanic Asian individuals, and 2.10 times higher among non-Hispanic Black individuals than among non-Hispanic White individuals.
• Individuals with a college education and higher income level were 24% and 41% less likely, respectively, to be diagnosed with diabetes.

IN PRACTICE:

“Improving access to quality care, implementing diabetes prevention programs focusing on high-risk groups, and addressing social determinants through multilevel interventions may help curb the diabetes epidemic in the United States,” the authors wrote.

SOURCE:

The study, led by Sulakshan Neupane, MS, Department of Agricultural and Applied Economics, University of Georgia, Athens, Georgia, was published online in Diabetes, Obesity, and Metabolism.

LIMITATIONS:

The self-reported diagnoses and lack of clinical data may have introduced bias. Diabetes prevalence could not be analyzed in South-East Asian and South Asian populations owing to limitations in the data collection process.

DISCLOSURES:

The study was not supported by any funding, and no potential author disclosures or conflicts were identified.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

Diabetes and prediabetes are associated with accelerated brain aging with brain age gaps of 2.29 and 0.50 years, respectively. This association is more pronounced in men and those with poor cardiometabolic health but may be mitigated by a healthy lifestyle.

METHODOLOGY:

• Diabetes is a known risk factor for cognitive impairment, dementia, and global brain atrophy but conflicting results have been reported for prediabetes, and it’s unknown whether a healthy lifestyle can counteract the negative impact of prediabetes.
• Researchers examined the cross-sectional and longitudinal relationship between hyperglycemia and brain aging, as well as the potential mitigating effect of a healthy lifestyle in 31,229 dementia-free adults (mean age, 54.8 years; 53% women) from the UK Biobank, including 13,518 participants with prediabetes and 1149 with diabetes.
• The glycemic status of the participants was determined by their medical history, medication use, and A1c levels.
• The brain age gap was calculated as a difference between chronologic age and brain age estimated from MRI data from six modalities vs several hundred brain MRI phenotypes that were modeled from a subset of healthy individuals.
• The role of sex, cardiometabolic risk factors, and a healthy lifestyle and their association with brain age was also explored, with a healthy lifestyle defined as never smoking, no or light or moderate alcohol consumption, and high physical activity.

TAKEAWAY:

• Prediabetes and diabetes were associated with a higher brain age gap than normoglycemia (beta-coefficient, 0.22 and 2.01; 95% CI, 0.10-0.34 and 1.70-2.32, respectively), and diabetes was more pronounced in men vs women and those with a higher vs lower burden of cardiometabolic risk factors.
• The brain ages of those with prediabetes and diabetes were 0.50 years and 2.29 years older on average than their respective chronologic ages.
• In an exploratory longitudinal analysis of the 2414 participants with two brain MRI scans, diabetes was linked to a 0.27-year annual increase in the brain age gap, and higher A1c, but not prediabetes, was associated with a significant increase in brain age gap.
• A healthy lifestyle attenuated the association between diabetes and a higher brain age gap (P = .003), reducing it by 1.68 years, also with a significant interaction between glycemic status and lifestyle.

IN PRACTICE:

“Our findings highlight diabetes and prediabetes as ideal targets for lifestyle-based interventions to promote brain health,” the authors wrote.

SOURCE:

This study, led by Abigail Dove, Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden, was published online in Diabetes Care.

LIMITATIONS:

The generalizability of the findings was limited due to a healthy volunteer bias in the UK Biobank. A high proportion of missing data prevented the inclusion of diet in the healthy lifestyle construct. Reverse causality may be possible as an older brain may contribute to the development of prediabetes by making it more difficult to manage medical conditions and adhere to a healthy lifestyle. A1c levels were measured only at baseline, preventing the assessment of changes in glycemic control over time.

DISCLOSURES:

The authors reported receiving funding from the Swedish Research Council; Swedish Research Council for Health, Working Life and Welfare; Karolinska Institutet Board of Research; Riksbankens Jubileumsfond; Marianne and Marcus Wallenberg Foundation; Alzheimerfonden; and Demensfonden. They declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Diabetes and prediabetes are associated with accelerated brain aging with brain age gaps of 2.29 and 0.50 years, respectively. This association is more pronounced in men and those with poor cardiometabolic health but may be mitigated by a healthy lifestyle.

METHODOLOGY:

• Diabetes is a known risk factor for cognitive impairment, dementia, and global brain atrophy but conflicting results have been reported for prediabetes, and it’s unknown whether a healthy lifestyle can counteract the negative impact of prediabetes.
• Researchers examined the cross-sectional and longitudinal relationship between hyperglycemia and brain aging, as well as the potential mitigating effect of a healthy lifestyle in 31,229 dementia-free adults (mean age, 54.8 years; 53% women) from the UK Biobank, including 13,518 participants with prediabetes and 1149 with diabetes.
• The glycemic status of the participants was determined by their medical history, medication use, and A1c levels.
• The brain age gap was calculated as a difference between chronologic age and brain age estimated from MRI data from six modalities vs several hundred brain MRI phenotypes that were modeled from a subset of healthy individuals.
• The role of sex, cardiometabolic risk factors, and a healthy lifestyle and their association with brain age was also explored, with a healthy lifestyle defined as never smoking, no or light or moderate alcohol consumption, and high physical activity.

TAKEAWAY:

• Prediabetes and diabetes were associated with a higher brain age gap than normoglycemia (beta-coefficient, 0.22 and 2.01; 95% CI, 0.10-0.34 and 1.70-2.32, respectively), and diabetes was more pronounced in men vs women and those with a higher vs lower burden of cardiometabolic risk factors.
• The brain ages of those with prediabetes and diabetes were 0.50 years and 2.29 years older on average than their respective chronologic ages.
• In an exploratory longitudinal analysis of the 2414 participants with two brain MRI scans, diabetes was linked to a 0.27-year annual increase in the brain age gap, and higher A1c, but not prediabetes, was associated with a significant increase in brain age gap.
• A healthy lifestyle attenuated the association between diabetes and a higher brain age gap (P = .003), reducing it by 1.68 years, also with a significant interaction between glycemic status and lifestyle.

IN PRACTICE:

“Our findings highlight diabetes and prediabetes as ideal targets for lifestyle-based interventions to promote brain health,” the authors wrote.

SOURCE:

This study, led by Abigail Dove, Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden, was published online in Diabetes Care.

LIMITATIONS:

The generalizability of the findings was limited due to a healthy volunteer bias in the UK Biobank. A high proportion of missing data prevented the inclusion of diet in the healthy lifestyle construct. Reverse causality may be possible as an older brain may contribute to the development of prediabetes by making it more difficult to manage medical conditions and adhere to a healthy lifestyle. A1c levels were measured only at baseline, preventing the assessment of changes in glycemic control over time.

DISCLOSURES:

The authors reported receiving funding from the Swedish Research Council; Swedish Research Council for Health, Working Life and Welfare; Karolinska Institutet Board of Research; Riksbankens Jubileumsfond; Marianne and Marcus Wallenberg Foundation; Alzheimerfonden; and Demensfonden. They declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Diabetes and prediabetes are associated with accelerated brain aging with brain age gaps of 2.29 and 0.50 years, respectively. This association is more pronounced in men and those with poor cardiometabolic health but may be mitigated by a healthy lifestyle.

METHODOLOGY:

• Diabetes is a known risk factor for cognitive impairment, dementia, and global brain atrophy but conflicting results have been reported for prediabetes, and it’s unknown whether a healthy lifestyle can counteract the negative impact of prediabetes.
• Researchers examined the cross-sectional and longitudinal relationship between hyperglycemia and brain aging, as well as the potential mitigating effect of a healthy lifestyle in 31,229 dementia-free adults (mean age, 54.8 years; 53% women) from the UK Biobank, including 13,518 participants with prediabetes and 1149 with diabetes.
• The glycemic status of the participants was determined by their medical history, medication use, and A1c levels.
• The brain age gap was calculated as a difference between chronologic age and brain age estimated from MRI data from six modalities vs several hundred brain MRI phenotypes that were modeled from a subset of healthy individuals.
• The role of sex, cardiometabolic risk factors, and a healthy lifestyle and their association with brain age was also explored, with a healthy lifestyle defined as never smoking, no or light or moderate alcohol consumption, and high physical activity.

TAKEAWAY:

• Prediabetes and diabetes were associated with a higher brain age gap than normoglycemia (beta-coefficient, 0.22 and 2.01; 95% CI, 0.10-0.34 and 1.70-2.32, respectively), and diabetes was more pronounced in men vs women and those with a higher vs lower burden of cardiometabolic risk factors.
• The brain ages of those with prediabetes and diabetes were 0.50 years and 2.29 years older on average than their respective chronologic ages.
• In an exploratory longitudinal analysis of the 2414 participants with two brain MRI scans, diabetes was linked to a 0.27-year annual increase in the brain age gap, and higher A1c, but not prediabetes, was associated with a significant increase in brain age gap.
• A healthy lifestyle attenuated the association between diabetes and a higher brain age gap (P = .003), reducing it by 1.68 years, also with a significant interaction between glycemic status and lifestyle.

IN PRACTICE:

“Our findings highlight diabetes and prediabetes as ideal targets for lifestyle-based interventions to promote brain health,” the authors wrote.

SOURCE:

This study, led by Abigail Dove, Aging Research Center, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden, was published online in Diabetes Care.

LIMITATIONS:

The generalizability of the findings was limited due to a healthy volunteer bias in the UK Biobank. A high proportion of missing data prevented the inclusion of diet in the healthy lifestyle construct. Reverse causality may be possible as an older brain may contribute to the development of prediabetes by making it more difficult to manage medical conditions and adhere to a healthy lifestyle. A1c levels were measured only at baseline, preventing the assessment of changes in glycemic control over time.

DISCLOSURES:

The authors reported receiving funding from the Swedish Research Council; Swedish Research Council for Health, Working Life and Welfare; Karolinska Institutet Board of Research; Riksbankens Jubileumsfond; Marianne and Marcus Wallenberg Foundation; Alzheimerfonden; and Demensfonden. They declared no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

A version of this article first appeared on Medscape.com.

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

A version of this article first appeared on Medscape.com.

Air pollution, high temperatures, and metabolic risk factors are driving global increases in stroke, contributing to 12 million cases and more than 7 million deaths from stroke each year, new data from the Global Burden of Disease (GBD) study showed.

Between 1990 and 2021, the number of people who experienced a stroke increased to 11.9 million (up by 70% since 1990), while the number of stroke survivors rose to 93.8 million (up by 86%), and stroke-related deaths rose to 7.3 million (up by 44%), making stroke the third leading cause of death worldwide after ischemic heart disease and COVID-19, investigators found.

Stroke is highly preventable, the investigators noted, with 84% of the stroke burden in 2021 attributable to 23 modifiable risk factors, including air pollution, excess body weight, high blood pressure, smoking, and physical inactivity.

This means there are “tremendous opportunities to alter the trajectory of stroke risk for the next generation,” Catherine O. Johnson, MPH, PhD, co-author and lead research scientist at the Institute for Health Metrics and Evaluation (IHME), University of Washington, Seattle, said in a news release.

The study was published online in The Lancet Neurology.
 

Top Risk Factor for Subarachnoid Hemorrhage

Since 1990, the contribution of high temperatures to poor health and early death due to stroke has risen 72%, a trend likely to increase in the future — underscoring the impact of environmental factors on the growing stroke burden, the authors said.

“Given that ambient air pollution is reciprocally linked with ambient temperature and climate change, the importance of urgent climate actions and measures to reduce air pollution cannot be overestimated,” Dr. Johnson said.

Mitchell S.V. Elkind, MD, MS, chief clinical science officer for the American Heart Association, who wasn’t involved in the study, told this news organization that environmental factors such as air pollution, particulate matter from wildfires and other sources, and excessive heat are now recognized as major contributors to the risk for stroke. “This should not be surprising as we have long recognized the risks of stroke associated with toxins in cigarette smoke, which likely share mechanisms for vascular damage with pollutants,” Dr. Elkind said.

The data also reveal for the first time that ambient particulate matter air pollution is a top risk factor for subarachnoid hemorrhage, contributing to 14% of the death and disability caused by this serious stroke subtype, on a par with smoking.

Dr. Elkind noted that smoking is “a major risk factor for subarachnoid hemorrhage. It makes sense that particulate air pollution would therefore similarly be a risk factor for subarachnoid hemorrhage, which similarly damages blood vessels. Prior studies were likely too small or did not assess the role of air pollution in subarachnoid hemorrhage.”

The analysis also showed substantial increases between 1990 and 2021 in the global stroke burden linked to high body mass index (up by 88%), high blood sugar (up 32%), a diet high in sugar-sweetened drinks (up 23%), low physical activity (up 11%), high systolic blood pressure (up 7%), and a diet low in omega-6 polyunsaturated fatty acids (up 5%).

“And with increasing exposure to risk factors such as high blood sugar and diet high in sugar-sweetened drinks, there is a critical need for interventions focused on obesity and metabolic syndromes,” Dr. Johnson said.

“Identifying sustainable ways to work with communities to take action to prevent and control modifiable risk factors for stroke is essential to address this growing crisis,” she added.
 

Prevention Strategies Fall Short

The data also showed that stroke-related disability-adjusted life-years rose from around 121.4 million years of healthy life lost in 1990 to 160.5 million years in 2021, making stroke the fourth leading cause of health loss worldwide after COVID-19, ischemic heart disease, and neonatal disorders.

“The global growth of the number of people who develop stroke and died from or remain disabled by stroke is growing fast, strongly suggesting that currently used stroke prevention strategies are not sufficiently effective,” lead author Valery L. Feigin, MD, PhD, from Auckland University of Technology, Auckland, New Zealand, and affiliate professor at IHME, said in the release.

“New, proven effective population-wide and motivational individual prevention strategies that could be applied to all people at risk of having a stroke, regardless of the level of risk, as recommended in the recent Lancet Neurology Commission on Stroke should be implemented across the globe urgently,” said Dr. Feigin.

Dr. Elkind said the AHA supports research on the effects of air quality on risk for vascular injury and stroke and has “long advocated for policies to mitigate the adverse health impacts of air pollutants, including reduction of vehicle emissions and renewable portfolio standards, taking into account racial, ethnic, and economic disparities.”

“AHA, and the healthcare sector more broadly, must take a leadership role in recommending policies to improve environmental air quality and in working with the private sector and industry to improve air quality,” Dr. Elkind said.

In an accompanying commentary, Ming Liu, MD, and Simiao Wu, MD, PhD, West China Hospital, Sichuan University, Chengdu, China, wrote that “pragmatic solutions to the enormous and increasing stroke burden include surveillance, prevention, acute care, and rehabilitation.”

“Surveillance strategies include establishing a national-level framework for regular monitoring of stroke burden, risk factors, and healthcare services via community-based surveys and health records,” they noted.

“Artificial intelligence and mobile technologies might not only facilitate the dissemination of evidence-based health services but also increase the number of data sources and encourage participation of multidisciplinary collaborators, potentially improving the validity and accuracy of future GBD estimates,” they added.

This study was funded by the Bill & Melinda Gates Foundation. Author disclosures are listed with the original article.

A version of this article first appeared on Medscape.com.

The US Federal Trade Commission (FTC) has sued the nation’s three largest pharmacy benefit managers (PBMs), alleging that they have steered patients to buying higher-priced insulins so that they can reap more profits.

The federal agency took action against CVS Health’s Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum and their respective group purchasing organizations — Zinc Health Services, Ascent Health Services, and Emisar Pharma Services. The three PBMs administer 80% of prescriptions in the United States, the FTC said in a statement announcing the action.

The agency filed an administrative complaint, which means its allegations will be tried in a formal hearing before an administrative law judge. It will not be heard in a criminal court.

The three PBMs “have extracted millions of dollars off the backs of patients who need life-saving medications,” Rahul Rao, deputy director of the FTC’s Bureau of Competition, said in the statement.

The FTC action is not the first taken by a government agency against PBMs. Ohio Attorney General Dave Yost sued Express Scripts and Prime Therapeutics in March 2023, alleging antitrust violations.

The FTC’s complaint, which is not yet public, alleges that PBMs excluded lower-priced insulins from their formularies “in favor of high list price, highly rebated insulin products.”

The FTC describes a market in which PBMs, as they consolidated market power, began to extract higher rebates from drug makers. In turn, insulin manufacturers started raising their prices. That allowed PBMs to collect larger rebates, even as drug makers profited, according to the FTC.

The PBMs “engaged in unfair methods of competition and unfair acts or practices under Section 5 of the FTC Act by incentivizing manufacturers to inflate insulin list prices, restricting patients’ access to more affordable insulins on drug formularies and shifting the cost of high list price insulins to vulnerable patient populations,” said the FTC, in its statement.

Andrea Nelson, chief legal officer for The Cigna Group, said in a statement that the lawsuit “continues a troubling pattern from the FTC of unsubstantiated and ideologically-driven attacks on pharmacy benefit managers, following the FTC’s biased and misleading July 2024 report, which Express Scripts demanded the Commission retract earlier this week.”
 

Conduct ‘Raises Serious Concerns’

Drug makers are not off the hook, said the FTC. Mr. Rao said in a separate statement that “all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns and that the Bureau of Competition may recommend suing drug manufacturers in any future enforcement actions.”

The lawsuit comes on the heels of a report issued by the FTC in July, in which it accused the industry of driving small pharmacies out of business and of having extraordinary control over where Americans access prescription drugs and how much they pay.

The agency also noted in that report that some PBMs had still not responded to its requests for information, some 2 years after first asking.

Cigna’s Express Scripts sued the FTC on September 17, 2024, claiming that the report hurt the company’s reputation.

The report is “74 pages of unsupported innuendo leveled against Express Scripts and other PBMs under a false and defamatory headline and accompanied by a false and defamatory press release,” said the Cigna suit.

Cigna is seeking to have the report scrubbed from the FTC website and an injunction that would bar FTC Chairwoman Lina Khan from participating in any FTC business relating to Express Scripts.

Cigna’s Ms. Nelson accused the FTC of trying to “score political points” and said that forcing PBMs to include some drugs on its formularies “will drive drug prices higher in this country.”

CVS Health’s Caremark and UnitedHealth’s Optum also pushed back, as did the industry trade group, the Pharmaceutical Care Management Association.

“This action not only fails to accurately consider the role of the entire prescription drug supply chain, but disregards positive progress, supported by PBMs, in making insulin more affordable for patients,” the association said in a statement. “In contrast to the rhetoric, the current insulin market is actually working, with PBMs effectively leveraging greater competition to drive down insulin prices and doing their part to make insulin affordable for patients through innovative programs,” said the group.

“The FTC has missed the mark entirely,” David Whitrap, vice president for external affairs at CVS Health, said in a statement emailed to this news organization.

CVS Health members “on average pay less than $25, far below list prices and far below the Biden Administration’s $35 cap,” said Mr. Whitrap, who added that the PBM had protected customers from “pharma price-gouging.”

UnitedHealth’s Optum also said that it had reduced insulin prices for members to an average of less than $18 per month. “This baseless action demonstrates a profound misunderstanding of how drug pricing works,” wrote Elizabeth Hoff, a spokesperson for UnitedHealth’s Optum Rx, in an email to this news organization.
 

A version of this article appeared on Medscape.com.

The US Federal Trade Commission (FTC) has sued the nation’s three largest pharmacy benefit managers (PBMs), alleging that they have steered patients to buying higher-priced insulins so that they can reap more profits.

The federal agency took action against CVS Health’s Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum and their respective group purchasing organizations — Zinc Health Services, Ascent Health Services, and Emisar Pharma Services. The three PBMs administer 80% of prescriptions in the United States, the FTC said in a statement announcing the action.

The agency filed an administrative complaint, which means its allegations will be tried in a formal hearing before an administrative law judge. It will not be heard in a criminal court.

The three PBMs “have extracted millions of dollars off the backs of patients who need life-saving medications,” Rahul Rao, deputy director of the FTC’s Bureau of Competition, said in the statement.

The FTC action is not the first taken by a government agency against PBMs. Ohio Attorney General Dave Yost sued Express Scripts and Prime Therapeutics in March 2023, alleging antitrust violations.

The FTC’s complaint, which is not yet public, alleges that PBMs excluded lower-priced insulins from their formularies “in favor of high list price, highly rebated insulin products.”

The FTC describes a market in which PBMs, as they consolidated market power, began to extract higher rebates from drug makers. In turn, insulin manufacturers started raising their prices. That allowed PBMs to collect larger rebates, even as drug makers profited, according to the FTC.

The PBMs “engaged in unfair methods of competition and unfair acts or practices under Section 5 of the FTC Act by incentivizing manufacturers to inflate insulin list prices, restricting patients’ access to more affordable insulins on drug formularies and shifting the cost of high list price insulins to vulnerable patient populations,” said the FTC, in its statement.

Andrea Nelson, chief legal officer for The Cigna Group, said in a statement that the lawsuit “continues a troubling pattern from the FTC of unsubstantiated and ideologically-driven attacks on pharmacy benefit managers, following the FTC’s biased and misleading July 2024 report, which Express Scripts demanded the Commission retract earlier this week.”
 

Conduct ‘Raises Serious Concerns’

Drug makers are not off the hook, said the FTC. Mr. Rao said in a separate statement that “all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns and that the Bureau of Competition may recommend suing drug manufacturers in any future enforcement actions.”

The lawsuit comes on the heels of a report issued by the FTC in July, in which it accused the industry of driving small pharmacies out of business and of having extraordinary control over where Americans access prescription drugs and how much they pay.

The agency also noted in that report that some PBMs had still not responded to its requests for information, some 2 years after first asking.

Cigna’s Express Scripts sued the FTC on September 17, 2024, claiming that the report hurt the company’s reputation.

The report is “74 pages of unsupported innuendo leveled against Express Scripts and other PBMs under a false and defamatory headline and accompanied by a false and defamatory press release,” said the Cigna suit.

Cigna is seeking to have the report scrubbed from the FTC website and an injunction that would bar FTC Chairwoman Lina Khan from participating in any FTC business relating to Express Scripts.

Cigna’s Ms. Nelson accused the FTC of trying to “score political points” and said that forcing PBMs to include some drugs on its formularies “will drive drug prices higher in this country.”

CVS Health’s Caremark and UnitedHealth’s Optum also pushed back, as did the industry trade group, the Pharmaceutical Care Management Association.

“This action not only fails to accurately consider the role of the entire prescription drug supply chain, but disregards positive progress, supported by PBMs, in making insulin more affordable for patients,” the association said in a statement. “In contrast to the rhetoric, the current insulin market is actually working, with PBMs effectively leveraging greater competition to drive down insulin prices and doing their part to make insulin affordable for patients through innovative programs,” said the group.

“The FTC has missed the mark entirely,” David Whitrap, vice president for external affairs at CVS Health, said in a statement emailed to this news organization.

CVS Health members “on average pay less than $25, far below list prices and far below the Biden Administration’s $35 cap,” said Mr. Whitrap, who added that the PBM had protected customers from “pharma price-gouging.”

UnitedHealth’s Optum also said that it had reduced insulin prices for members to an average of less than $18 per month. “This baseless action demonstrates a profound misunderstanding of how drug pricing works,” wrote Elizabeth Hoff, a spokesperson for UnitedHealth’s Optum Rx, in an email to this news organization.
 

A version of this article appeared on Medscape.com.

The US Federal Trade Commission (FTC) has sued the nation’s three largest pharmacy benefit managers (PBMs), alleging that they have steered patients to buying higher-priced insulins so that they can reap more profits.

The federal agency took action against CVS Health’s Caremark, Cigna’s Express Scripts, and UnitedHealth Group’s Optum and their respective group purchasing organizations — Zinc Health Services, Ascent Health Services, and Emisar Pharma Services. The three PBMs administer 80% of prescriptions in the United States, the FTC said in a statement announcing the action.

The agency filed an administrative complaint, which means its allegations will be tried in a formal hearing before an administrative law judge. It will not be heard in a criminal court.

The three PBMs “have extracted millions of dollars off the backs of patients who need life-saving medications,” Rahul Rao, deputy director of the FTC’s Bureau of Competition, said in the statement.

The FTC action is not the first taken by a government agency against PBMs. Ohio Attorney General Dave Yost sued Express Scripts and Prime Therapeutics in March 2023, alleging antitrust violations.

The FTC’s complaint, which is not yet public, alleges that PBMs excluded lower-priced insulins from their formularies “in favor of high list price, highly rebated insulin products.”

The FTC describes a market in which PBMs, as they consolidated market power, began to extract higher rebates from drug makers. In turn, insulin manufacturers started raising their prices. That allowed PBMs to collect larger rebates, even as drug makers profited, according to the FTC.

The PBMs “engaged in unfair methods of competition and unfair acts or practices under Section 5 of the FTC Act by incentivizing manufacturers to inflate insulin list prices, restricting patients’ access to more affordable insulins on drug formularies and shifting the cost of high list price insulins to vulnerable patient populations,” said the FTC, in its statement.

Andrea Nelson, chief legal officer for The Cigna Group, said in a statement that the lawsuit “continues a troubling pattern from the FTC of unsubstantiated and ideologically-driven attacks on pharmacy benefit managers, following the FTC’s biased and misleading July 2024 report, which Express Scripts demanded the Commission retract earlier this week.”
 

Conduct ‘Raises Serious Concerns’

Drug makers are not off the hook, said the FTC. Mr. Rao said in a separate statement that “all drug manufacturers should be on notice that their participation in the type of conduct challenged here raises serious concerns and that the Bureau of Competition may recommend suing drug manufacturers in any future enforcement actions.”

The lawsuit comes on the heels of a report issued by the FTC in July, in which it accused the industry of driving small pharmacies out of business and of having extraordinary control over where Americans access prescription drugs and how much they pay.

The agency also noted in that report that some PBMs had still not responded to its requests for information, some 2 years after first asking.

Cigna’s Express Scripts sued the FTC on September 17, 2024, claiming that the report hurt the company’s reputation.

The report is “74 pages of unsupported innuendo leveled against Express Scripts and other PBMs under a false and defamatory headline and accompanied by a false and defamatory press release,” said the Cigna suit.

Cigna is seeking to have the report scrubbed from the FTC website and an injunction that would bar FTC Chairwoman Lina Khan from participating in any FTC business relating to Express Scripts.

Cigna’s Ms. Nelson accused the FTC of trying to “score political points” and said that forcing PBMs to include some drugs on its formularies “will drive drug prices higher in this country.”

CVS Health’s Caremark and UnitedHealth’s Optum also pushed back, as did the industry trade group, the Pharmaceutical Care Management Association.

“This action not only fails to accurately consider the role of the entire prescription drug supply chain, but disregards positive progress, supported by PBMs, in making insulin more affordable for patients,” the association said in a statement. “In contrast to the rhetoric, the current insulin market is actually working, with PBMs effectively leveraging greater competition to drive down insulin prices and doing their part to make insulin affordable for patients through innovative programs,” said the group.

“The FTC has missed the mark entirely,” David Whitrap, vice president for external affairs at CVS Health, said in a statement emailed to this news organization.

CVS Health members “on average pay less than $25, far below list prices and far below the Biden Administration’s $35 cap,” said Mr. Whitrap, who added that the PBM had protected customers from “pharma price-gouging.”

UnitedHealth’s Optum also said that it had reduced insulin prices for members to an average of less than $18 per month. “This baseless action demonstrates a profound misunderstanding of how drug pricing works,” wrote Elizabeth Hoff, a spokesperson for UnitedHealth’s Optum Rx, in an email to this news organization.
 

A version of this article appeared on Medscape.com.

Patients with obesity or type 2 diabetes (T2D) who stuck with their medication for a year lost more weight with semaglutide than with liraglutide, a new study reported.

Researchers at the Cleveland Clinic reviewed records for 3389 adult patients with obesity who were prescribed one of the glucagon-like peptide 1 (GLP-1) medications for either T2D or obesity between 2015 and 2022. They found that patients who took either semaglutide or liraglutide for obesity were more likely to lose weight than those prescribed the medications for T2D and that semaglutide was associated with greater weight loss.

The study, published in JAMA Network Open, identified “key characteristics that could inform the probability of achieving sustained weight loss of a magnitude large enough to provide clinically significant health benefits,” said lead author Hamlet Gasoyan, PhD, a staff investigator at the Center for Value-Based Care Research in the Department of Internal Medicine of Primary Care Institute, Cleveland Clinic, Cleveland.

Only about 40% of patients continued to take the medications at 1 year. Those who did not continue did not achieve the same level of weight loss, Dr. Gasoyan told this news organization. He and his colleagues will study the factors that lead patients to stop taking the medications in a future paper.

The results from the current paper give patients and clinicians reasonable expectations on the trajectory of weight loss when the drugs are prescribed for diabetes vs obesity, said Dr. Gasoyan, assistant professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland.
 

Semaglutide Superior

Because of the study’s timeframe, the majority of GLP-1s were prescribed for T2D. Liraglutide was approved (as Saxenda) for obesity in December 2020 and semaglutide (as Wegovy) for obesity in June 2021.

The authors were able to capture fills under the brand names and doses approved by the US Food and Drug Administration (FDA) for obesity (Wegovy, 1.7 or 2.4 mg; Saxenda, 3.0 mg), as well as those approved for T2D (Ozempic, 0.5, 1.0, or 2.0 mg; Victoza, 1.2 or 1.8 mg).

The researchers reported that among the 3389 patients, 1341 (39.6%) were prescribed semaglutide and 1444 (42.6%) were prescribed liraglutide for T2D. For obesity, 227 (6.7%) were prescribed liraglutide, and 377 (11.1%) were prescribed semaglutide.

Overall, those with diabetes had a −3.2% mean weight change compared with those with obesity who had a −5.9% mean weight change.

Semaglutide consistently outperformed liraglutide, particularly in obesity.

Overall, at 1 year, the mean percentage weight change among those with obesity was −5.1% with semaglutide compared with −2.2% with liraglutide (P < .001). 

At 1 year, among those with obesity who were persistent in semaglutide use (defined as 90-275 medication days) had a mean body weight of −12.9% vs −5.6% in those taking liraglutide.

Overall, about 40% of patients were persistent at 1 year. But the figure was higher for semaglutide (45.8%) and lower for liraglutide (35.6%).

Liraglutide requires daily injections compared with semaglutide that requires weekly injections. The authors did not study the reasons for medication adherence or discontinuation.

Key factors for achieving a greater than 10% weight loss — considered clinically meaningful — included taking semaglutide, receiving a GLP-1 for obesity, persistent medication use, high dosage, and being female.
 

Real-World Data Welcomed

Michael Weintraub, MD, an obesity medicine specialist and clinical assistant professor at NYU Langone Health, New York City, said that having real-world data on GLP-1 effectiveness has been much needed.

The researchers “did a really good job at stratifying these patients,” he told this news organization, saying that the study “adds to the literature in terms of what we might expect and what things we should look out for when we want to obtain the maximum degree of weight loss and attain overall better metabolic health for our patients.”

One strength: The researchers were able to capture when someone actually filled a prescription, he said. Clinicians don’t always know whether a prescription for a GLP-1 has been filled because patients might go without the drug because of insurance hurdles or supply issues, he said.

Dr. Weintraub was not surprised that the study showed that both GLP-1s produced more weight loss in those with obesity than in those with T2D, as that has become a common finding. No one has been able to explain why there is such a difference, said Dr. Weintraub. “As a field, we actually don’t know the reason behind that yet,” he said.

Given the small number of patients prescribed semaglutide for obesity, that “limits the generalizability,” he said.

Even so, semaglutide is increasingly proving superior, Dr. Weintraub said. “I would reach towards semaglutide every time either for individuals with type 2 diabetes or individuals with obesity,” he said. “The major limitation, though, is insurance coverage rather than, unfortunately, my clinical decision-making.”

He also still sees a role for liraglutide. It will go off patent soon and that could “lead to a lower price point and hopefully greater access for patients,” he said.

Dr. Gasoyan and Dr. Weintraub reported no relevant financial relationships. One coauthor reported receiving advisory board fees from Novo Nordisk and research funding from Eli Lilly during the conduct of the study.
 

A version of this article first appeared on Medscape.com.

Patients with obesity or type 2 diabetes (T2D) who stuck with their medication for a year lost more weight with semaglutide than with liraglutide, a new study reported.

Researchers at the Cleveland Clinic reviewed records for 3389 adult patients with obesity who were prescribed one of the glucagon-like peptide 1 (GLP-1) medications for either T2D or obesity between 2015 and 2022. They found that patients who took either semaglutide or liraglutide for obesity were more likely to lose weight than those prescribed the medications for T2D and that semaglutide was associated with greater weight loss.

The study, published in JAMA Network Open, identified “key characteristics that could inform the probability of achieving sustained weight loss of a magnitude large enough to provide clinically significant health benefits,” said lead author Hamlet Gasoyan, PhD, a staff investigator at the Center for Value-Based Care Research in the Department of Internal Medicine of Primary Care Institute, Cleveland Clinic, Cleveland.

Only about 40% of patients continued to take the medications at 1 year. Those who did not continue did not achieve the same level of weight loss, Dr. Gasoyan told this news organization. He and his colleagues will study the factors that lead patients to stop taking the medications in a future paper.

The results from the current paper give patients and clinicians reasonable expectations on the trajectory of weight loss when the drugs are prescribed for diabetes vs obesity, said Dr. Gasoyan, assistant professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland.
 

Semaglutide Superior

Because of the study’s timeframe, the majority of GLP-1s were prescribed for T2D. Liraglutide was approved (as Saxenda) for obesity in December 2020 and semaglutide (as Wegovy) for obesity in June 2021.

The authors were able to capture fills under the brand names and doses approved by the US Food and Drug Administration (FDA) for obesity (Wegovy, 1.7 or 2.4 mg; Saxenda, 3.0 mg), as well as those approved for T2D (Ozempic, 0.5, 1.0, or 2.0 mg; Victoza, 1.2 or 1.8 mg).

The researchers reported that among the 3389 patients, 1341 (39.6%) were prescribed semaglutide and 1444 (42.6%) were prescribed liraglutide for T2D. For obesity, 227 (6.7%) were prescribed liraglutide, and 377 (11.1%) were prescribed semaglutide.

Overall, those with diabetes had a −3.2% mean weight change compared with those with obesity who had a −5.9% mean weight change.

Semaglutide consistently outperformed liraglutide, particularly in obesity.

Overall, at 1 year, the mean percentage weight change among those with obesity was −5.1% with semaglutide compared with −2.2% with liraglutide (P < .001). 

At 1 year, among those with obesity who were persistent in semaglutide use (defined as 90-275 medication days) had a mean body weight of −12.9% vs −5.6% in those taking liraglutide.

Overall, about 40% of patients were persistent at 1 year. But the figure was higher for semaglutide (45.8%) and lower for liraglutide (35.6%).

Liraglutide requires daily injections compared with semaglutide that requires weekly injections. The authors did not study the reasons for medication adherence or discontinuation.

Key factors for achieving a greater than 10% weight loss — considered clinically meaningful — included taking semaglutide, receiving a GLP-1 for obesity, persistent medication use, high dosage, and being female.
 

Real-World Data Welcomed

Michael Weintraub, MD, an obesity medicine specialist and clinical assistant professor at NYU Langone Health, New York City, said that having real-world data on GLP-1 effectiveness has been much needed.

The researchers “did a really good job at stratifying these patients,” he told this news organization, saying that the study “adds to the literature in terms of what we might expect and what things we should look out for when we want to obtain the maximum degree of weight loss and attain overall better metabolic health for our patients.”

One strength: The researchers were able to capture when someone actually filled a prescription, he said. Clinicians don’t always know whether a prescription for a GLP-1 has been filled because patients might go without the drug because of insurance hurdles or supply issues, he said.

Dr. Weintraub was not surprised that the study showed that both GLP-1s produced more weight loss in those with obesity than in those with T2D, as that has become a common finding. No one has been able to explain why there is such a difference, said Dr. Weintraub. “As a field, we actually don’t know the reason behind that yet,” he said.

Given the small number of patients prescribed semaglutide for obesity, that “limits the generalizability,” he said.

Even so, semaglutide is increasingly proving superior, Dr. Weintraub said. “I would reach towards semaglutide every time either for individuals with type 2 diabetes or individuals with obesity,” he said. “The major limitation, though, is insurance coverage rather than, unfortunately, my clinical decision-making.”

He also still sees a role for liraglutide. It will go off patent soon and that could “lead to a lower price point and hopefully greater access for patients,” he said.

Dr. Gasoyan and Dr. Weintraub reported no relevant financial relationships. One coauthor reported receiving advisory board fees from Novo Nordisk and research funding from Eli Lilly during the conduct of the study.
 

A version of this article first appeared on Medscape.com.

Patients with obesity or type 2 diabetes (T2D) who stuck with their medication for a year lost more weight with semaglutide than with liraglutide, a new study reported.

Researchers at the Cleveland Clinic reviewed records for 3389 adult patients with obesity who were prescribed one of the glucagon-like peptide 1 (GLP-1) medications for either T2D or obesity between 2015 and 2022. They found that patients who took either semaglutide or liraglutide for obesity were more likely to lose weight than those prescribed the medications for T2D and that semaglutide was associated with greater weight loss.

The study, published in JAMA Network Open, identified “key characteristics that could inform the probability of achieving sustained weight loss of a magnitude large enough to provide clinically significant health benefits,” said lead author Hamlet Gasoyan, PhD, a staff investigator at the Center for Value-Based Care Research in the Department of Internal Medicine of Primary Care Institute, Cleveland Clinic, Cleveland.

Only about 40% of patients continued to take the medications at 1 year. Those who did not continue did not achieve the same level of weight loss, Dr. Gasoyan told this news organization. He and his colleagues will study the factors that lead patients to stop taking the medications in a future paper.

The results from the current paper give patients and clinicians reasonable expectations on the trajectory of weight loss when the drugs are prescribed for diabetes vs obesity, said Dr. Gasoyan, assistant professor of medicine at Cleveland Clinic Lerner College of Medicine of Case Western Reserve University, Cleveland.
 

Semaglutide Superior

Because of the study’s timeframe, the majority of GLP-1s were prescribed for T2D. Liraglutide was approved (as Saxenda) for obesity in December 2020 and semaglutide (as Wegovy) for obesity in June 2021.

The authors were able to capture fills under the brand names and doses approved by the US Food and Drug Administration (FDA) for obesity (Wegovy, 1.7 or 2.4 mg; Saxenda, 3.0 mg), as well as those approved for T2D (Ozempic, 0.5, 1.0, or 2.0 mg; Victoza, 1.2 or 1.8 mg).

The researchers reported that among the 3389 patients, 1341 (39.6%) were prescribed semaglutide and 1444 (42.6%) were prescribed liraglutide for T2D. For obesity, 227 (6.7%) were prescribed liraglutide, and 377 (11.1%) were prescribed semaglutide.

Overall, those with diabetes had a −3.2% mean weight change compared with those with obesity who had a −5.9% mean weight change.

Semaglutide consistently outperformed liraglutide, particularly in obesity.

Overall, at 1 year, the mean percentage weight change among those with obesity was −5.1% with semaglutide compared with −2.2% with liraglutide (P < .001). 

At 1 year, among those with obesity who were persistent in semaglutide use (defined as 90-275 medication days) had a mean body weight of −12.9% vs −5.6% in those taking liraglutide.

Overall, about 40% of patients were persistent at 1 year. But the figure was higher for semaglutide (45.8%) and lower for liraglutide (35.6%).

Liraglutide requires daily injections compared with semaglutide that requires weekly injections. The authors did not study the reasons for medication adherence or discontinuation.

Key factors for achieving a greater than 10% weight loss — considered clinically meaningful — included taking semaglutide, receiving a GLP-1 for obesity, persistent medication use, high dosage, and being female.
 

Real-World Data Welcomed

Michael Weintraub, MD, an obesity medicine specialist and clinical assistant professor at NYU Langone Health, New York City, said that having real-world data on GLP-1 effectiveness has been much needed.

The researchers “did a really good job at stratifying these patients,” he told this news organization, saying that the study “adds to the literature in terms of what we might expect and what things we should look out for when we want to obtain the maximum degree of weight loss and attain overall better metabolic health for our patients.”

One strength: The researchers were able to capture when someone actually filled a prescription, he said. Clinicians don’t always know whether a prescription for a GLP-1 has been filled because patients might go without the drug because of insurance hurdles or supply issues, he said.

Dr. Weintraub was not surprised that the study showed that both GLP-1s produced more weight loss in those with obesity than in those with T2D, as that has become a common finding. No one has been able to explain why there is such a difference, said Dr. Weintraub. “As a field, we actually don’t know the reason behind that yet,” he said.

Given the small number of patients prescribed semaglutide for obesity, that “limits the generalizability,” he said.

Even so, semaglutide is increasingly proving superior, Dr. Weintraub said. “I would reach towards semaglutide every time either for individuals with type 2 diabetes or individuals with obesity,” he said. “The major limitation, though, is insurance coverage rather than, unfortunately, my clinical decision-making.”

He also still sees a role for liraglutide. It will go off patent soon and that could “lead to a lower price point and hopefully greater access for patients,” he said.

Dr. Gasoyan and Dr. Weintraub reported no relevant financial relationships. One coauthor reported receiving advisory board fees from Novo Nordisk and research funding from Eli Lilly during the conduct of the study.
 

A version of this article first appeared on Medscape.com.

TOPLINE:

Optimal management of blood pressure, A1c levels, low-density lipoprotein cholesterol (LDL-C), albuminuria, smoking, and physical activity may reduce the excess risk for chronic kidney disease (CKD) typically linked to obesity. The protective effect is more pronounced in men, in those with lower healthy food scores, and in users of diabetes medication.

METHODOLOGY:

• Obesity is a significant risk factor for CKD, but it is unknown if managing multiple other obesity-related CKD risk factors can mitigate the excess CKD risk.
• Researchers assessed CKD risk factor control in 97,538 participants with obesity from the UK Biobank and compared them with an equal number of age- and sex-matched control participants with normal body weight and no CKD at baseline.
• Participants with obesity were assessed for six modifiable risk factors: Blood pressure, A1c levels, LDL-C, albuminuria, smoking, and physical activity.
• Overall, 2487, 12,720, 32,388, 36,988, and 15,381 participants with obesity had at most two, three, four, five, and six risk factors under combined control, respectively, with the two or fewer group serving as the reference.
• The primary outcome was incident CKD and the degree of combined risk factor control in persons. The CKD risk and risk factor control in participants with obesity were also compared with CKD incidence in matched normal weight participants.

TAKEAWAY:

• During a median follow-up period of 10.8 years, 3954 cases of incident CKD were reported in participants with obesity and 1498 cases in matched persons of normal body mass index (BMI).
• In a stepwise pattern, optimal control of each additional risk factor was associated with 11% (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.86-0.91) reduction in the incidence of CKD events, down to a 49% reduction in CKD incidence (aHR, 0.51; 95% CI, 0.43-0.61) for combined control of all six risk factors in participants with obesity.
• The protective effect of combined control of risk factors was more pronounced in men vs women, in those with lower vs higher healthy diet scores, and in users vs nonusers of diabetes medication.
• A similar stepwise pattern emerged between the number of risk factors controlled and CKD risk in participants with obesity compared with matched individuals of normal BMI, with the excess CKD risk eliminated in participants with obesity with six risk factors under control.

IN PRACTICE:

“Comprehensive control of risk factors might effectively neutralize the excessive CKD risk associated with obesity, emphasizing the potential of a joint management approach in the prevention of CKD in this population,” the authors wrote.

SOURCE:

The study was led by Rui Tang, MS, Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The evaluated risk factors for CKD were arbitrarily selected, which may not represent the ideal group. The study did not consider the time-varying effect of joint risk factor control owing to the lack of some variables such as A1c. The generalizability of the findings was limited because over 90% of the UK Biobank cohort is composed of White people and individuals with healthier behaviors compared with the overall UK population.

DISCLOSURES:

The study was supported by grants from the US National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Optimal management of blood pressure, A1c levels, low-density lipoprotein cholesterol (LDL-C), albuminuria, smoking, and physical activity may reduce the excess risk for chronic kidney disease (CKD) typically linked to obesity. The protective effect is more pronounced in men, in those with lower healthy food scores, and in users of diabetes medication.

METHODOLOGY:

• Obesity is a significant risk factor for CKD, but it is unknown if managing multiple other obesity-related CKD risk factors can mitigate the excess CKD risk.
• Researchers assessed CKD risk factor control in 97,538 participants with obesity from the UK Biobank and compared them with an equal number of age- and sex-matched control participants with normal body weight and no CKD at baseline.
• Participants with obesity were assessed for six modifiable risk factors: Blood pressure, A1c levels, LDL-C, albuminuria, smoking, and physical activity.
• Overall, 2487, 12,720, 32,388, 36,988, and 15,381 participants with obesity had at most two, three, four, five, and six risk factors under combined control, respectively, with the two or fewer group serving as the reference.
• The primary outcome was incident CKD and the degree of combined risk factor control in persons. The CKD risk and risk factor control in participants with obesity were also compared with CKD incidence in matched normal weight participants.

TAKEAWAY:

• During a median follow-up period of 10.8 years, 3954 cases of incident CKD were reported in participants with obesity and 1498 cases in matched persons of normal body mass index (BMI).
• In a stepwise pattern, optimal control of each additional risk factor was associated with 11% (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.86-0.91) reduction in the incidence of CKD events, down to a 49% reduction in CKD incidence (aHR, 0.51; 95% CI, 0.43-0.61) for combined control of all six risk factors in participants with obesity.
• The protective effect of combined control of risk factors was more pronounced in men vs women, in those with lower vs higher healthy diet scores, and in users vs nonusers of diabetes medication.
• A similar stepwise pattern emerged between the number of risk factors controlled and CKD risk in participants with obesity compared with matched individuals of normal BMI, with the excess CKD risk eliminated in participants with obesity with six risk factors under control.

IN PRACTICE:

“Comprehensive control of risk factors might effectively neutralize the excessive CKD risk associated with obesity, emphasizing the potential of a joint management approach in the prevention of CKD in this population,” the authors wrote.

SOURCE:

The study was led by Rui Tang, MS, Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The evaluated risk factors for CKD were arbitrarily selected, which may not represent the ideal group. The study did not consider the time-varying effect of joint risk factor control owing to the lack of some variables such as A1c. The generalizability of the findings was limited because over 90% of the UK Biobank cohort is composed of White people and individuals with healthier behaviors compared with the overall UK population.

DISCLOSURES:

The study was supported by grants from the US National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Optimal management of blood pressure, A1c levels, low-density lipoprotein cholesterol (LDL-C), albuminuria, smoking, and physical activity may reduce the excess risk for chronic kidney disease (CKD) typically linked to obesity. The protective effect is more pronounced in men, in those with lower healthy food scores, and in users of diabetes medication.

METHODOLOGY:

• Obesity is a significant risk factor for CKD, but it is unknown if managing multiple other obesity-related CKD risk factors can mitigate the excess CKD risk.
• Researchers assessed CKD risk factor control in 97,538 participants with obesity from the UK Biobank and compared them with an equal number of age- and sex-matched control participants with normal body weight and no CKD at baseline.
• Participants with obesity were assessed for six modifiable risk factors: Blood pressure, A1c levels, LDL-C, albuminuria, smoking, and physical activity.
• Overall, 2487, 12,720, 32,388, 36,988, and 15,381 participants with obesity had at most two, three, four, five, and six risk factors under combined control, respectively, with the two or fewer group serving as the reference.
• The primary outcome was incident CKD and the degree of combined risk factor control in persons. The CKD risk and risk factor control in participants with obesity were also compared with CKD incidence in matched normal weight participants.

TAKEAWAY:

• During a median follow-up period of 10.8 years, 3954 cases of incident CKD were reported in participants with obesity and 1498 cases in matched persons of normal body mass index (BMI).
• In a stepwise pattern, optimal control of each additional risk factor was associated with 11% (adjusted hazard ratio [aHR], 0.89; 95% CI, 0.86-0.91) reduction in the incidence of CKD events, down to a 49% reduction in CKD incidence (aHR, 0.51; 95% CI, 0.43-0.61) for combined control of all six risk factors in participants with obesity.
• The protective effect of combined control of risk factors was more pronounced in men vs women, in those with lower vs higher healthy diet scores, and in users vs nonusers of diabetes medication.
• A similar stepwise pattern emerged between the number of risk factors controlled and CKD risk in participants with obesity compared with matched individuals of normal BMI, with the excess CKD risk eliminated in participants with obesity with six risk factors under control.

IN PRACTICE:

“Comprehensive control of risk factors might effectively neutralize the excessive CKD risk associated with obesity, emphasizing the potential of a joint management approach in the prevention of CKD in this population,” the authors wrote.

SOURCE:

The study was led by Rui Tang, MS, Department of Epidemiology, School of Public Health and Tropical Medicine, Tulane University, New Orleans, Louisiana. It was published online in Diabetes, Obesity and Metabolism.

LIMITATIONS:

The evaluated risk factors for CKD were arbitrarily selected, which may not represent the ideal group. The study did not consider the time-varying effect of joint risk factor control owing to the lack of some variables such as A1c. The generalizability of the findings was limited because over 90% of the UK Biobank cohort is composed of White people and individuals with healthier behaviors compared with the overall UK population.

DISCLOSURES:

The study was supported by grants from the US National Heart, Lung, and Blood Institute and the National Institute of Diabetes and Digestive and Kidney Diseases. The authors declared no conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

MADRID — A new consensus statement in development will aim to advise on best practices for navigating the transition of youth with diabetes from pediatric to adult diabetes care, despite limited data.

Expected to be released in early 2025, the statement will be a joint effort of the International Society for Pediatric and Adolescent Diabetes (ISPAD), the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD). It will provide guidance on advance transition planning, the care transfer itself, and follow-up. Writing panel members presented an update on the statement’s development on September 13, 2024, at EASD’s annual meeting.

The care transition period is critical because “adolescents and young adults are the least likely of all age groups to achieve glycemic targets for a variety of physiological and psychosocial reasons ... Up to 60% of these individuals don’t transfer successfully from pediatric to adult care, with declines in attendance, adverse medical outcomes, and mental health challenges,” Frank J. Snoek, PhD, emeritus professor of medical psychology at Amsterdam University Medical College, Amsterdam, the Netherlands, said in introductory remarks at the EASD session.

Session chair Carine De Beaufort, MD, a pediatric endocrinologist in Luxembourg City, Luxembourg, told this news organization, “We know it’s a continuing process, which is extremely important for young people to move into the world. The last formal recommendations were published in 2011, so we thought it was time for an update. What we realized in doing a systematic review and scoping review is that there are a lot of suggestions and ideas not really associated with robust data, and it’s not so easy to get good outcome indicators.”

The final statement will provide clinical guidance but, at the same time, “will be very transparent where more work is needed,” she said.

Sarah Lyons, MD, associate professor of pediatrics at Baylor College of Medicine, Houston, broadly outlined the document. Pre-transition planning will include readiness assessments for transfer from pediatric to adult care. The transfer phase will include measures to prevent gaps in care. And the post-transition phase will cover incorporation into adult care, with follow-up of the individual’s progress for a period.

Across the three stages, the document is expected to recommend a multidisciplinary team approach including psychological support, education and assessment, family and peer support, and care coordination. It will also address practical considerations for patients and professionals including costs and insurance.

It will build upon previous guidelines, including those of ADA and general guidance on transition from pediatric to adult healthcare from the American Academy of Pediatrics. “Ideally, this process will be continuous, comprehensive, coordinated, individualized, and developmentally appropriate,” Dr. Lyons said.
 

‘It Shouldn’t Be Just One Conversation ... It Needs to Be a Process’

Asked to comment, ISPAD president David Maahs, MD, the Lucile Salter Packard Professor of Pediatrics and Division Chief of Pediatric Endocrinology at Stanford University, Palo Alto, California, told this news organization, “It shouldn’t be just one conversation and one visit. It needs to be a process where you talk about the need to transition to adult endocrine care and prepare the person with diabetes and their family for that transition. One of the challenges is if they don’t make it to that first appointment and you assume that they did, and then that’s one place where there can be a gap that people fall through the two systems.”

Dr. Maahs added, “Another issue that’s a big problem in the United States is that children lose their parents’ insurance at 26 ... Some become uninsured after that, or their insurance plan isn’t accepted by the adult provider.”
 

‘There Does Not Appear to Be Sufficient Data’

Steven James, PhD, RN, of the University of the Sunshine Coast, Brisbane, Australia, presented the limited data upon which the statement will be based. A systematic literature review yielded just 26 intervention trials looking at care transition for youth with type 1 or type 2 diabetes, including seven clinical trials with only one randomized.

In that trial, in which 205 youth aged 17-20 years were randomized to a structured 18-month transition program with a transition coordinator, the intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but the benefits weren’t maintained 12 months after completion of the intervention.

The other trials produced mixed results in terms of metabolic outcomes, with improvements in A1c and reductions in diabetic ketoacidosis and hospitalizations seen in some but not others. Healthcare outcomes and utilization, psychosocial outcomes, transition-related knowledge, self-care, and care satisfaction were only occasionally assessed, Dr. James noted.

“The field is lacking empirically supported interventions that can improve patient physiologic and psychologic outcomes, prevent poor clinic attendance, and improve patient satisfaction in medical care ... There still does not appear to be sufficient data related to the impact of transition readiness or transfer-to-adult care programs.”
 

‘Quite a Lot of Variation in Practices Worldwide’

Dr. James also presented results from two online surveys undertaken by the document writing panel. One recently published survey in Diabetes Research and Clinical Practice examined healthcare professionals’ experiences and perceptions around diabetes care transitions. Of 372 respondents (75% physicians) from around the world — including a third in low-middle-income countries — fewer than half reported using transition readiness checklists (32.8%), provided written transition information (29.6%), or had a dedicated staff member to aid in the process (23.7%).

Similarly, few involved a psychologist (25.3%) or had a structured transition education program (22.6%). Even in high-income countries, fewer than half reported using these measures. Overall, a majority (91.9%) reported barriers to offering patients a positive transition experience.

“This shows to me that there is quite a lot of variation in practices worldwide ... There is a pressing need for an international consensus transition guideline,” Dr. James said.

Among the respondents’ beliefs, 53.8% thought that discussions about transitioning should be initiated at ages 15-17 years, while 27.8% thought 12-14 years was more appropriate. Large majorities favored use of a transition readiness checklist (93.6%), combined transition clinics (80.6%), having a dedicated transition coordinator/staff member available (85.8%), and involving a psychologist in the transition process (80.6%).

A similar survey of patients and carers will be published soon and will be included in the new statement’s evidence base, Dr. James said.

Dr. Maahs said that endorsement of the upcoming guidance from three different medical societies should help raise the profile of the issue. “Hopefully three professional organizations are able to speak with a united and louder voice than if it was just one group or one set of authors. I think this consensus statement can raise awareness, improve care, and help advocate for better care.”

Dr. De Beaufort, Dr. James, and Dr. Lyons had no disclosures. Dr. Snoek is an adviser/speaker for Abbott, Lilly, Novo Nordisk, and Sanofi and receives funding from Breakthrough T1D, Sanofi, and Novo Nordisk. Dr. Maahs has had research support from the National Institutes of Health, Breakthrough T1D, National Science Foundation, and the Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, LifeScan, MannKind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, BioSpex, Provention Bio, Kriya, Enable Biosciences, and Bayer.
 

A version of this article first appeared on Medscape.com.

MADRID — A new consensus statement in development will aim to advise on best practices for navigating the transition of youth with diabetes from pediatric to adult diabetes care, despite limited data.

Expected to be released in early 2025, the statement will be a joint effort of the International Society for Pediatric and Adolescent Diabetes (ISPAD), the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD). It will provide guidance on advance transition planning, the care transfer itself, and follow-up. Writing panel members presented an update on the statement’s development on September 13, 2024, at EASD’s annual meeting.

The care transition period is critical because “adolescents and young adults are the least likely of all age groups to achieve glycemic targets for a variety of physiological and psychosocial reasons ... Up to 60% of these individuals don’t transfer successfully from pediatric to adult care, with declines in attendance, adverse medical outcomes, and mental health challenges,” Frank J. Snoek, PhD, emeritus professor of medical psychology at Amsterdam University Medical College, Amsterdam, the Netherlands, said in introductory remarks at the EASD session.

Session chair Carine De Beaufort, MD, a pediatric endocrinologist in Luxembourg City, Luxembourg, told this news organization, “We know it’s a continuing process, which is extremely important for young people to move into the world. The last formal recommendations were published in 2011, so we thought it was time for an update. What we realized in doing a systematic review and scoping review is that there are a lot of suggestions and ideas not really associated with robust data, and it’s not so easy to get good outcome indicators.”

The final statement will provide clinical guidance but, at the same time, “will be very transparent where more work is needed,” she said.

Sarah Lyons, MD, associate professor of pediatrics at Baylor College of Medicine, Houston, broadly outlined the document. Pre-transition planning will include readiness assessments for transfer from pediatric to adult care. The transfer phase will include measures to prevent gaps in care. And the post-transition phase will cover incorporation into adult care, with follow-up of the individual’s progress for a period.

Across the three stages, the document is expected to recommend a multidisciplinary team approach including psychological support, education and assessment, family and peer support, and care coordination. It will also address practical considerations for patients and professionals including costs and insurance.

It will build upon previous guidelines, including those of ADA and general guidance on transition from pediatric to adult healthcare from the American Academy of Pediatrics. “Ideally, this process will be continuous, comprehensive, coordinated, individualized, and developmentally appropriate,” Dr. Lyons said.
 

‘It Shouldn’t Be Just One Conversation ... It Needs to Be a Process’

Asked to comment, ISPAD president David Maahs, MD, the Lucile Salter Packard Professor of Pediatrics and Division Chief of Pediatric Endocrinology at Stanford University, Palo Alto, California, told this news organization, “It shouldn’t be just one conversation and one visit. It needs to be a process where you talk about the need to transition to adult endocrine care and prepare the person with diabetes and their family for that transition. One of the challenges is if they don’t make it to that first appointment and you assume that they did, and then that’s one place where there can be a gap that people fall through the two systems.”

Dr. Maahs added, “Another issue that’s a big problem in the United States is that children lose their parents’ insurance at 26 ... Some become uninsured after that, or their insurance plan isn’t accepted by the adult provider.”
 

‘There Does Not Appear to Be Sufficient Data’

Steven James, PhD, RN, of the University of the Sunshine Coast, Brisbane, Australia, presented the limited data upon which the statement will be based. A systematic literature review yielded just 26 intervention trials looking at care transition for youth with type 1 or type 2 diabetes, including seven clinical trials with only one randomized.

In that trial, in which 205 youth aged 17-20 years were randomized to a structured 18-month transition program with a transition coordinator, the intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but the benefits weren’t maintained 12 months after completion of the intervention.

The other trials produced mixed results in terms of metabolic outcomes, with improvements in A1c and reductions in diabetic ketoacidosis and hospitalizations seen in some but not others. Healthcare outcomes and utilization, psychosocial outcomes, transition-related knowledge, self-care, and care satisfaction were only occasionally assessed, Dr. James noted.

“The field is lacking empirically supported interventions that can improve patient physiologic and psychologic outcomes, prevent poor clinic attendance, and improve patient satisfaction in medical care ... There still does not appear to be sufficient data related to the impact of transition readiness or transfer-to-adult care programs.”
 

‘Quite a Lot of Variation in Practices Worldwide’

Dr. James also presented results from two online surveys undertaken by the document writing panel. One recently published survey in Diabetes Research and Clinical Practice examined healthcare professionals’ experiences and perceptions around diabetes care transitions. Of 372 respondents (75% physicians) from around the world — including a third in low-middle-income countries — fewer than half reported using transition readiness checklists (32.8%), provided written transition information (29.6%), or had a dedicated staff member to aid in the process (23.7%).

Similarly, few involved a psychologist (25.3%) or had a structured transition education program (22.6%). Even in high-income countries, fewer than half reported using these measures. Overall, a majority (91.9%) reported barriers to offering patients a positive transition experience.

“This shows to me that there is quite a lot of variation in practices worldwide ... There is a pressing need for an international consensus transition guideline,” Dr. James said.

Among the respondents’ beliefs, 53.8% thought that discussions about transitioning should be initiated at ages 15-17 years, while 27.8% thought 12-14 years was more appropriate. Large majorities favored use of a transition readiness checklist (93.6%), combined transition clinics (80.6%), having a dedicated transition coordinator/staff member available (85.8%), and involving a psychologist in the transition process (80.6%).

A similar survey of patients and carers will be published soon and will be included in the new statement’s evidence base, Dr. James said.

Dr. Maahs said that endorsement of the upcoming guidance from three different medical societies should help raise the profile of the issue. “Hopefully three professional organizations are able to speak with a united and louder voice than if it was just one group or one set of authors. I think this consensus statement can raise awareness, improve care, and help advocate for better care.”

Dr. De Beaufort, Dr. James, and Dr. Lyons had no disclosures. Dr. Snoek is an adviser/speaker for Abbott, Lilly, Novo Nordisk, and Sanofi and receives funding from Breakthrough T1D, Sanofi, and Novo Nordisk. Dr. Maahs has had research support from the National Institutes of Health, Breakthrough T1D, National Science Foundation, and the Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, LifeScan, MannKind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, BioSpex, Provention Bio, Kriya, Enable Biosciences, and Bayer.
 

A version of this article first appeared on Medscape.com.

MADRID — A new consensus statement in development will aim to advise on best practices for navigating the transition of youth with diabetes from pediatric to adult diabetes care, despite limited data.

Expected to be released in early 2025, the statement will be a joint effort of the International Society for Pediatric and Adolescent Diabetes (ISPAD), the American Diabetes Association (ADA), and the European Association for the Study of Diabetes (EASD). It will provide guidance on advance transition planning, the care transfer itself, and follow-up. Writing panel members presented an update on the statement’s development on September 13, 2024, at EASD’s annual meeting.

The care transition period is critical because “adolescents and young adults are the least likely of all age groups to achieve glycemic targets for a variety of physiological and psychosocial reasons ... Up to 60% of these individuals don’t transfer successfully from pediatric to adult care, with declines in attendance, adverse medical outcomes, and mental health challenges,” Frank J. Snoek, PhD, emeritus professor of medical psychology at Amsterdam University Medical College, Amsterdam, the Netherlands, said in introductory remarks at the EASD session.

Session chair Carine De Beaufort, MD, a pediatric endocrinologist in Luxembourg City, Luxembourg, told this news organization, “We know it’s a continuing process, which is extremely important for young people to move into the world. The last formal recommendations were published in 2011, so we thought it was time for an update. What we realized in doing a systematic review and scoping review is that there are a lot of suggestions and ideas not really associated with robust data, and it’s not so easy to get good outcome indicators.”

The final statement will provide clinical guidance but, at the same time, “will be very transparent where more work is needed,” she said.

Sarah Lyons, MD, associate professor of pediatrics at Baylor College of Medicine, Houston, broadly outlined the document. Pre-transition planning will include readiness assessments for transfer from pediatric to adult care. The transfer phase will include measures to prevent gaps in care. And the post-transition phase will cover incorporation into adult care, with follow-up of the individual’s progress for a period.

Across the three stages, the document is expected to recommend a multidisciplinary team approach including psychological support, education and assessment, family and peer support, and care coordination. It will also address practical considerations for patients and professionals including costs and insurance.

It will build upon previous guidelines, including those of ADA and general guidance on transition from pediatric to adult healthcare from the American Academy of Pediatrics. “Ideally, this process will be continuous, comprehensive, coordinated, individualized, and developmentally appropriate,” Dr. Lyons said.
 

‘It Shouldn’t Be Just One Conversation ... It Needs to Be a Process’

Asked to comment, ISPAD president David Maahs, MD, the Lucile Salter Packard Professor of Pediatrics and Division Chief of Pediatric Endocrinology at Stanford University, Palo Alto, California, told this news organization, “It shouldn’t be just one conversation and one visit. It needs to be a process where you talk about the need to transition to adult endocrine care and prepare the person with diabetes and their family for that transition. One of the challenges is if they don’t make it to that first appointment and you assume that they did, and then that’s one place where there can be a gap that people fall through the two systems.”

Dr. Maahs added, “Another issue that’s a big problem in the United States is that children lose their parents’ insurance at 26 ... Some become uninsured after that, or their insurance plan isn’t accepted by the adult provider.”
 

‘There Does Not Appear to Be Sufficient Data’

Steven James, PhD, RN, of the University of the Sunshine Coast, Brisbane, Australia, presented the limited data upon which the statement will be based. A systematic literature review yielded just 26 intervention trials looking at care transition for youth with type 1 or type 2 diabetes, including seven clinical trials with only one randomized.

In that trial, in which 205 youth aged 17-20 years were randomized to a structured 18-month transition program with a transition coordinator, the intervention was associated with increased clinic attendance, improved satisfaction with care, and decreased diabetes-related distress, but the benefits weren’t maintained 12 months after completion of the intervention.

The other trials produced mixed results in terms of metabolic outcomes, with improvements in A1c and reductions in diabetic ketoacidosis and hospitalizations seen in some but not others. Healthcare outcomes and utilization, psychosocial outcomes, transition-related knowledge, self-care, and care satisfaction were only occasionally assessed, Dr. James noted.

“The field is lacking empirically supported interventions that can improve patient physiologic and psychologic outcomes, prevent poor clinic attendance, and improve patient satisfaction in medical care ... There still does not appear to be sufficient data related to the impact of transition readiness or transfer-to-adult care programs.”
 

‘Quite a Lot of Variation in Practices Worldwide’

Dr. James also presented results from two online surveys undertaken by the document writing panel. One recently published survey in Diabetes Research and Clinical Practice examined healthcare professionals’ experiences and perceptions around diabetes care transitions. Of 372 respondents (75% physicians) from around the world — including a third in low-middle-income countries — fewer than half reported using transition readiness checklists (32.8%), provided written transition information (29.6%), or had a dedicated staff member to aid in the process (23.7%).

Similarly, few involved a psychologist (25.3%) or had a structured transition education program (22.6%). Even in high-income countries, fewer than half reported using these measures. Overall, a majority (91.9%) reported barriers to offering patients a positive transition experience.

“This shows to me that there is quite a lot of variation in practices worldwide ... There is a pressing need for an international consensus transition guideline,” Dr. James said.

Among the respondents’ beliefs, 53.8% thought that discussions about transitioning should be initiated at ages 15-17 years, while 27.8% thought 12-14 years was more appropriate. Large majorities favored use of a transition readiness checklist (93.6%), combined transition clinics (80.6%), having a dedicated transition coordinator/staff member available (85.8%), and involving a psychologist in the transition process (80.6%).

A similar survey of patients and carers will be published soon and will be included in the new statement’s evidence base, Dr. James said.

Dr. Maahs said that endorsement of the upcoming guidance from three different medical societies should help raise the profile of the issue. “Hopefully three professional organizations are able to speak with a united and louder voice than if it was just one group or one set of authors. I think this consensus statement can raise awareness, improve care, and help advocate for better care.”

Dr. De Beaufort, Dr. James, and Dr. Lyons had no disclosures. Dr. Snoek is an adviser/speaker for Abbott, Lilly, Novo Nordisk, and Sanofi and receives funding from Breakthrough T1D, Sanofi, and Novo Nordisk. Dr. Maahs has had research support from the National Institutes of Health, Breakthrough T1D, National Science Foundation, and the Helmsley Charitable Trust, and his institution has had research support from Medtronic, Dexcom, Insulet, Bigfoot Biomedical, Tandem, and Roche. He has consulted for Abbott, Aditxt, the Helmsley Charitable Trust, LifeScan, MannKind, Sanofi, Novo Nordisk, Eli Lilly, Medtronic, Insulet, Dompe, BioSpex, Provention Bio, Kriya, Enable Biosciences, and Bayer.
 

A version of this article first appeared on Medscape.com.